Note: Descriptions are shown in the official language in which they were submitted.
WO 2022/251749
PCT/US2022/031667
RECIPROCATING MIXING AND INJECTOR SYSTEM
CROSS-REFERENCE TO RELATED APPLICATIONS
[1] This application claims the benefit of U.S. Provisional Patent
Application number
63/194,408 filed on May 28, 2021; which is herein incorporated by reference in
entirety.
FIELD OF THE INVENTION
[2] The present invention relates generally to dual container devices for
reconstituting or
mixing medicament components.
BACKGROUND OF THE INVENTION
[3] Dual container/cartridge injector/autoinjectors are known for storing
drug components
separately until reconstitution or mixing at point of use. There are various
benefits to
therapeutics which may be preferred to be provided in a multi-chamber format.
The drug
may be more thermally stable, have a longer shelf life, or have other issues
being in its
aqueous form. Solubilizing drugs in liquid agents, suspending dry particles in
liquids, or
combining liquid-liquid solutions or suspensions thereof may be required for
similar
reasons.
1-41 In the field of use of multi-chambered
injector/autoinjectors, there are also drug
formulations where high-intensity and/or longer duration mixing is needed
after
recombination of the drug constituents prior to delivery of difficult to mix
drug products.
This may be due to low solubility of the drug, poor surface energy or
wettability of a powder
or microparticle for dissolution. Other needs include making a suspension of
particles
homogeneously dispersed within a solvent, solving problems with caking of a
dry phase
1
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
requiring initial energy for dispersion, or poor miscibility making
emulsification difficult. In
some cases, speed and ease-of-use may be critical for rescue applications
where an
emergency treatment needs to be delivered very quickly and with very few
steps. In this
field of use, state-of-the-art devices typically rely on a user shaking the
drug container to
mix, dissolve, or suspend the drug. Preparation can also require multiple
steps that include
changing out needles, or moving drug and diluent from one container to another
manually.
As a result of these additional user-required step, users may experience:
delays in treatment
time, inadequately mixed drugs, or become generally dissatisfied with the
experience of
using the product. In other cases, drugs may be formulated in less ideal ways
where users
may be required to inject a higher dose volume, endure a less comfortable
dosage form, a
larger than desirable delivery needle, be exposed to additional solubilizing
or stabilizing
agents added to the formulation, or be required to make more frequent
injections. There is
significant motivation to create a device that can improve upon the mixing of
drugs which
are otherwise difficult to solubilize, reconstitute, or suspend by re-
combination alone.
[5] The present application seeks to solve some of these identified
problems as well as
other problems that will become apparent to those skilled in the art.
SUMMARY OF THE INVENTION
[6] Several embodiments of drug mixing and drug delivery devices are
disclosed herein.
[71 In first embodiment of a mixing and drug delivery system
comprises: a housing
configured to hold a first container and a second container, where in the
first container
contains a first medicament component and the second container contains a
second
2
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
medicament component; a first seal associated with the first container; a
second seal
associated with the second container; a mixing activation mechanism; a fluid
communication
assembly having a fluidic channel configured to receive a first output from
the mixing
activation mechanism, whereupon receiving the first output from the mixing
activation
mechanism causes the fluid communication assembly to open, remove or otherwise
pierce the
first seal and the second seal and create a fluidic pathway between the first
container and the
second container; a mixing system configured to alternately transfer the first
and second
medicaments between the first and second containers during a mixing phase; a
pressurized
gas chamber at least partially disposed in the housing and configured to
receive a second
output from the mixing activation mechanism, whereupon receiving the second
output causes
the pressurized gas chamber to pressurize the mixing system; a mixing trigger
configured to
release a portion of pressurized gas that facilitates the transfer of the
first and second
medicaments components between the first and second containers by the mixing
system,
wherein the transfer between first and second containers causes the first and
second
medicament components to become a mixed medicament; and a needle delivery
assembly
configured to be in fluid communication with the first and second containers
during a
delivery phase.
[81 The mixing and drug delivery system of embodiment 1, wherein
the housing is
formed in a T-shape, and wherein the lower portion or shaft portion of the T-
shape forms a
handle.
[9] The mixing and drug delivery system of embodiment 1, wherein the mixing
activation
mechanism partially encloses the pressurized gas chamber.
[10] The mixing and drug delivery system of embodiment 1, wherein the mixing
system
further comprises a first gas-driven plunger associated with the first
container and a second
gas-driven plunger associated with the second container.
3
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[11] The mixing and drug delivery system of embodiment 4, wherein the mixing
system
further comprises a multi-directional valve configured to alternate the flow
of gas directed to
the first and second gas-driven plungers based on user input to the mixing
trigger.
[12] The mixing and drug delivery system of embodiment 5, whereupon receiving
the
second output also causes the mixing system to initially drive the first gas-
driven plunger to
transfer the first medicament component from the first container into the
second container
with the second medicament component.
[13] The mixing and drug delivery system of embodiment 5, whereupon a user
depressing
the mixing trigger causes a release of a portion of gas to drive either the
first or second gas-
driven plunger.
[14] The mixing and drug delivery system of embodiment 7, whereupon the user
releasing
the mixing trigger causes the release of a portion of gas to drive either the
first or second gas-
driven plunger.
[15] The mixing and drug delivery system of embodiment 7, whereupon each
subsequent
depressing of the mixing trigger by the user causes the release of a portion
of gas to be
alternately directed to drive either the first or second gas-driven plunger.
[16] The mixing and drug delivery system of embodiment 8, whereupon each
subsequent
releasing of the mixing button by the user causes the release of a portion of
gas to be
alternately directed to drive either the first or second gas-driven plunger.
[17] The mixing and drug delivery system of embodiment 1, wherein the fluid
communication assembly further includes a fluidic transfer channel that
fluidly connects the
first container and the second container upon receiving the first output to
the fluid
communication assembly.
4
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[18] The mixing and drug delivery system of embodiment 11, further including a
delivery
seal configured to prevent fluid communication between the fluidic transfer
channel and the
needle assembly during the mixing phase.
[19] The mixing and drug delivery system of embodiment 11, wherein the fluidic
transfer
channel and the needle assembly are configured to be in fluid communication,
and wherein
the needle assembly further includes a sterility barrier covering an injection
end of an
injection needle of the needle assembly.
[20] The mixing and drug delivery system of embodiment 12, wherein the needle
assembly
further includes a needle shield configured to be a bump trigger, and a needle
shield lockout
mechanism configured to maintain the needle shield in an extended state after
a delivery
phase.
[21] The mixing and drug delivery system of embodiment 14, further including a
delivery
actuation system having at least one stored energy and configured to drive the
needle of the
needle assembly into a user upon being activated by the bump trigger.
[22] The mixing and drug delivery system of embodiment 5, wherein the multi-
directional
valve includes a vent associated with each of the first and second gas-driven
plungers and
configured to release pressure from either the first or second gas-driven
plunger when a new
portion of gas released is directed at the alternate of the first and second
gas-driven plungers.
[23] The mixing and drug delivery system of embodiment 16, further including
at least one
vent obstruction component.
[24] The mixing and drug delivery system of embodiment 17, further including a
vent
lockout mechanism configured to move the at least one vent obstruction
component in a
position to block the flow of gas from exiting one of the vents of the multi-
directional valve.
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[25] The mixing and drug delivery system of embodiment 18, wherein the vent
lockout
mechanism includes a slide actuator having at least one ramped protrusion
configured to
interface with the at least one vent obstruction component.
[26] The mixing and drug delivery system of embodiment 18, wherein the vent
lockout
mechanism includes a camming component configured to interface with the at
least one vent
obstruction component.
[27] The mixing and drug delivery system of embodiment 19, wherein the slide
actuator
can be configured to be pressed, pulled or slid when the mixing trigger is
depressed.
[28] The mixing and drug delivery system of embodiment 20, wherein the camming
component can be configured to be pressed, pulled or slid when the mixing
trigger is
depressed.
[29] The mixing and drug delivery system of embodiment 19, wherein the slide
actuator
can be configured to be pressed, pulled or slid when the mixing trigger is
released.
[30] The mixing and drug delivery system of embodiment 20, wherein the camming
component can be configured to be pressed, pulled or slid when the mixing
trigger is
released.
[31] The mixing and drug delivery system of embodiment 17, wherein the at
least one vent
obstruction component is configured to block the flow of gas from exiting at
least one of the
vents of the multi-directional valve, which prevents the transfer of
medicament components
between the first and second containers.
[32] The mixing and drug delivery system of embodiment 25, whereupon creating
fluid
communication between the fluid communication assembly and the delivery needle
assemble
redirects energy associated with the pressurized to drive the medicament
components
disposed in either the first or second container to exit through the fluid
communication
assembly and out the delivery needle assembly.
6
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[33] A mixing and drug delivery system embodiment 27 comprising: a housing
configured
to hold a first container and a second container, where in the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
container; a first plunger associated with the first container; a second
plunger associated with
the second container; a mixing activation mechanism; a fluid channel having
two needles
configured to receive a first output from the mixing activation mechanism,
whereupon
receiving the first output from the mixing activation mechanism causes the
fluid channel to
open, remove or otherwise pierce the first seal and the second seal, and
create a fluidic
pathway between the first container and the second container; a pre-stored
energy source at
least partially disposed in the housing and configured to receive a second
output from the
mixing activation mechanism, whereupon receiving the second output causes the
pre-stored
energy source to exert a force on either the first or second plunger; a mixing
system
configured to release a portion of the pre-stored energy source that
facilitates the transfer of
the first and second medicaments components between the first and second
containers,
wherein the transfer between first and second containers causes the first and
second
medicament components to become a mixed medicament; and a needle delivery
assembly
configured to be in fluid communication with the first and second containers
during a
delivery phase.
[34] The mixing and drug delivery system of embodiment 27, wherein the mixing
activation mechanism is comprised of housing that is configured to be pulled
linearly and
rotated, wherein a linear pull causes the first output, and wherein a rotation
input causes the
second output.
7
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[35] The mixing and drug delivery system of embodiment 27, wherein the mixing
activation mechanism is comprised of housing that is configured to be rotated,
wherein a
rotation causes the first output and the second output.
[36] The mixing and drug delivery system of embodiment 27, wherein the mixing
system
further includes a multi-directional valve.
[37] The mixing and drug delivery system of embodiment 27, wherein the pre-
stored
energy source is a pressurized gas chamber.
[38] The mixing and drug delivery system of embodiment 31, wherein the
pressurized gas
chamber contains permanent gas or liquid.
[39] The mixing and drug delivery system of embodiment 27, wherein the mixing
system
further includes a mixing trigger.
[40] The mixing and drug delivery system of embodiment 27, wherein the
mixing system
further includes a regulator.
[41] The mixing and drug delivery system of embodiments 30 and 33, wherein
the mixing
system further includes a regulator.
[42] The mixing and drug delivery system of embodiment 35, wherein pressing
and
releasing the mixing trigger, causes the multi-directional valve to direct
pressurized gas from
the regulator through alternative paths that alternate exerting a force
between the first and
second plungers.
[43] The mixing and drug delivery system of embodiment 36, wherein the
exerting force
on the first and second plungers cause the medicament components to transfer
between the
first and second containers.
[44] The mixing and drug delivery system of embodiment 37, wherein the
medicament
components are transferred at least 1 time.
8
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[45] The mixing and drug delivery system of embodiment 37, wherein the
medicament
components are transferred at least 2 times.
[46] The mixing and drug delivery system of embodiment 37, wherein the
medicament
components are transferred more than 2 times.
[47] The mixing and drug delivery system of embodiment 37, wherein the
medicament
components are transferred at least 10 times, 20 times, 40 times, or more than
100 times.
[48] The mixing and drug delivery system of embodiment 37, further including a
vent
lockout mechanism.
[49] The mixing and drug delivery system of embodiment 27, wherein the mixing
activation mechanism is comprised of a pair of compressible mixing grips.
[50] The mixing and drug delivery system of embodiment 43, wherein a first
compression
of the mixing grips causes the first output.
[51] The mixing and drug delivery system of embodiment 43, wherein a first
release of the
mixing grips causes the second output.
[52] The mixing and drug delivery system of embodiment 27, wherein the mixing
system
further includes a release mechanism configured to release a portion of stored
energy.
[53] The mixing and drug delivery system of embodiment 46, wherein the pre-
stored
energy source is a compression spring or a constant force spring.
[54] The mixing and drug delivery system of embodiment 44, wherein the first
output
causes a direct force on the first plunger causing the first medicament
component to transfer
into the second container causing the first and second medicament components
to become a
mixed medicament.
[55] The mixing and drug delivery system of embodiment 48, wherein releasing
the
mixing grips causes a release of energy from the pre-stored energy source to
exert a force on
9
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
the second plunger causing the mixed medicament to transfer from the second
container to
the first container.
[56] The mixing and drug delivery system of embodiment 49, wherein additional
compressing and releasing of the mixing grips causes the mixed medicament to
transfer
between the first and second containers at least 1 time.
[57] The mixing and drug delivery system of embodiment 49, wherein additional
compressing and releasing of the mixing grips causes the mixed medicament to
transfer
between the first and second containers at least 2 times.
[58] The mixing and drug delivery system of embodiment 49, wherein additional
compressing and releasing of the mixing grips causes the mixed medicament to
transfer
between the first and second containers more than 2 times.
[59] The mixing and drug delivery system of embodiment 49, wherein additional
compressing and releasing of the mixing grips causes the mixed medicament to
transfer
between the first and second containers at least 10 times, 20 times, 40 times,
or more than
100 times.
[60] The mixing and drug delivery system of embodiment 27, wherein the mixing
activation mechanism is comprised of a lever that is configured to be extended
away from the
housing, wherein an extension of the lever causes the first output.
[61] The mixing and drug delivery system of embodiment 54, wherein a first
compression
of the lever causes the first medicament component in the first container to
transfer to the
second container causing the first and second medicament to become a mixed
medicament.
[62] The mixing and drug delivery system of embodiment 55, wherein a second
extension
of the lever causes the second output and a transfer of the mixed medicament
from the second
container to the first container.
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[63] The mixing and drug delivery system of embodiment 55, wherein the mixing
system
further includes a horizontal rack, pinion gear and vertical rack.
[64] The mixing and drug delivery system of embodiment 57, further includes a
rotary
lock.
[65] The mixing and drug delivery system of embodiment 55, further including a
sliding
lock configured to prevent an extension of the lever.
[66] The mixing and drug delivery system of embodiment 59. wherein the sliding
lock is
initially coupled to a safety cap, and upon removal of the safety cap causes
the sliding lock to
reposition and prevent the lever from extending.
[67] The mixing and drug delivery system of embodiment 56, wherein additional
compressions and extensions of the lever cause the mixed medicament to
transfer between
the first and second containers at least 1 time.
[68] The mixing and drug delivery system of embodiment 56, wherein additional
compressions and extensions of the lever cause the mixed medicament to
transfer between
the first and second containers at least 2 times.
[69] The mixing and drug delivery system of embodiment 56, wherein additional
compressions and extensions of the lever cause the mixed medicament to
transfer between
the first and second containers more than 2 times.
[70] The mixing and drug delivery system of embodiment 56, wherein additional
compressions and extensions of the lever cause the mixed medicament to
transfer between
the first and second containers at least 10 times, 20 times, 40 times, or more
than 100 times.
[71] A mixing and drug delivery system embodiment 65 comprising: a housing
configured
to hold a first container and a second container, where in the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
11
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
container; a first plunger associated with the first container; a second
plunger associated with
the second container; a mixing activation mechanism; a fluid channel having
two needles
configured to receive a first output from the mixing activation mechanism,
whereupon
receiving the first output from the mixing activation mechanism causes the
fluid channel to
open, remove or otherwise pierce the first seal and the second seal, and
create a fluidic
pathway between the first container and the second container; a pre-stored
energy source at
least partially disposed in the housing and configured to receive a second
output from the
mixing activation mechanism, whereupon receiving the second output causes the
pre-stored
energy source to exert a force on either the first or second plunger; and a
mixing system
configured to release a portion of the pre-stored energy source that
facilitates the transfer of
the first and second medicaments components between the first and second
containers,
wherein the transfer between first and second containers causes the first and
second
medicament components to become a mixed medicament.
[72] A mixing and drug delivery system embodiment 66 comprising: a housing
configured
to hold a first container and a second container, where in the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
container; a mixing activation mechanism; a mixing system having a mixing grip
assembly
that comprises a first grip that is stationary and extending from the housing
and a second grip
that is movable axially along a portion of the housing, wherein the first and
second grips of
the mixing grip assembly are configured to be compressed upon removing the
mixing
activation mechanism; a fluid communication assembly configured to receive a
first output
from the mixing system, whereupon receiving the first output from the mixing
system causes
the fluid communication assembly to open, remove or othenvise pierce the first
seal and the
second seal and connect a fluid pathway between the first and second
containers; and a
12
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
needle delivery system configured to be in fluid communication with the first
and second
containers during a delivery phase.
[73] The mixing and drug delivery system comprising of embodiment 66, wherein
the
mixing system further includes: a first plunger associated with the first
container and a
second plunger associated with the second container, a first plunger rod, a
second plunger
rod, a mechanically regenerative energy source, and a release mechanism, and
wherein the
first plunger rod is in direct mechanical communication with the second grip.
[74] The mixing and drug delivery system of embodiment 67, further including a
flange
associated with the second grip, which is configured to interface with and
laterally translate
the release mechanism.
[75] The mixing and drug delivery system of embodiment 68, wherein the release
mechanism includes a ramped portion that interfaces with the flange.
[76] The mixing and drug delivery system of embodiment 68, wherein the release
mechanism includes a ledge portion that interferingly engages with a notched
portion of the
second plunger rod to initially prevent the second plunger rod from moving
into the second
container.
[77] The mixing and drug delivery system of embodiment 67, wherein the
mechanically
regenerative energy source is configured to decompress or extend the first and
second mixing
grips, as the mechanically regenerative energy source drives the second
plunger rod into the
second container, which transfers the first and second medicaments components
now in a
mixed medicament form into the first container, which applies a pressure on
the first plunger
and first plunger rod, which in turn applies a force on the second grip
causing it to separate
away from the first grip.
[78] The mixing and drug delivery system of embodiment 71, wherein the first
and second
grips are configured to put energy back into the mechanically regenerative
energy source
13
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
through a user compressing the grips together once the release mechanism has
been laterally
translated to allow axial movement of the second plunger rod.
[79] The mixing and drug delivery system of embodiment 72, wherein the
mechanically
regenerative energy source is one of a compression spring or constant force
spring.
[80] The mixing and drug delivery system of embodiment 66, wherein the mixing
activation mechanism is a release pin.
[81] The mixing and drug delivery system of embodiment 66, wherein the mixing
activation mechanism is a safety release disposed between the first and second
grips.
[82] The mixing and drug delivery system of embodiment 72, wherein stored
energy
associated with the mechanically regenerative energy source can be redirected
to force the
mixed medicament from the second container through the needle delivery system,
upon the
needle delivery system becoming in fluid communication with the fluid
communication
assembly through piercing or otherwise removing a delivery septum, while
maintaining the
first and second grips in a compressed state.
[83] The mixing and drug delivery system of embodiment 76, wherein the needle
delivery
system includes a removable needle sheath.
[84] The mixing and drug delivery system of embodiment 76, wherein the needle
delivery
system can be axially translated into the fluid communication assembly.
[85] The mixing and drug delivery system of embodiment 76, wherein the needle
delivery
system can further have a needle shield assembly disposed about the needle
delivery system.
[86] The mixing and drug delivery system of embodiment 67, further including
an
engagement flange attached to the first plunger rod, which is configured to
interface with and
laterally translate the release mechanism.
[87] A drug mixing system that can be attached to an injector embodiment 81
comprising:
14
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[88] a housing configured to hold a first container and a second container,
where in the
first container contains a first medicament component and the second container
contains a
second medicament component; a first seal associated with the first container;
a second seal
associated with the second container; a mixing activation mechanism; a mixing
system
having a mixing grip assembly that comprises a first grip that is stationary
and extending
from the housing and a second grip that is movable axially along a portion of
the housing,
wherein the first and second grips of the mixing grip assembly are configured
to be
compressed upon removing the mixing activation mechanism; and a fluid
communication
assembly configured to receive a first output from the mixing system,
whereupon receiving
the first output from the mixing system causes the fluid communication
assembly to open,
remove or otherwise pierce the first seal and the second seal and connect a
fluid pathway
between the first and second containers.
[89] A drug mixing system that can be attached to an injector embodiment 82
comprising:
a housing configured to hold a first container and a second container, where
in the first
container contains a first medicament component and the second container
contains a second
medicament component; a first seal associated with the first container; a
second seal
associated with the second container; a mixing activation mechanism; a mixing
system
having a regenerative energy source and a mixing grip assembly that comprises
a first grip
that is stationary and extending from the housing and a second grip that is
movable axially
along a portion of the housing, wherein the first and second grips of the
mixing grip assembly
are configured to be compressed upon removing the mixing activation mechanism;
and a
fluid communication assembly configured to receive a first output from the
mixing system,
whereupon receiving the first output from the mixing system causes the fluid
communication
assembly to open, remove or otherwise pierce the first seal and the second
seal and connect a
fluid pathway between the first and second containers.
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[90] A drug mixing and injector system embodiment 83 comprising: a housing
configured
to hold a first container and a second container, wherein the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
container; a first plunger rod associated with the first container that is
mechanically
connected to a vertical rack that is mechanically driven by a pinion gear
assembly; a second
plunger rod associated with the second container that is mechanically
connected to a
regenerative energy source; a mixing system including a lever configured to
pivot about the
housing; a fluid communication assembly configured to receive a first output
from the mixing
system, whereupon receiving the first input from the mixing system causes the
fluid
communication assembly to open, remove or otherwise pierce the first seal and
the second
seal and connect a fluid pathway between the first and second containers; and
a needle
delivery system configured to be in fluid communication with the first and
second containers
via the fluid communication assembly during a delivery phase.
[91] The drug mixing and injector system of embodiment 83, wherein the mixing
system
further includes a rotatable horizontal rack coupled to the lever.
[92] The drug mixing and injector system of embodiment 84, wherein the lever
further
includes a camming surface that upon pivoting the lever about the housing
causes a first
output where the camming surface engages the fluid communication assembly and
creates
fluid communication between the first and second containers.
[93] The drug mixing and injector system of embodiment 84, further including a
rotary
lock in mechanical communication with the second plunger rod that prevents the
second
plunger rod from axially moving within the second container until rotated.
[94] The drug mixing and injector system of embodiment 86, wherein the rotary
lock
includes a keyed portion that is configured to rotate off a ledge formed in
the second plunger
16
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
rod and into a channel formed in the second plunger rod when the horizontal
rack interfaces
with the camming surface and causes the rotary lock to rotate.
[95] The drug mixing and injector system of embodiment 86, wherein the
horizontal rack
of the mixing system is configured to interface with a camming surface of the
rotary lock that
enables the horizontal rack to rotate the rotatory lock, which enables axially
movement of the
second plunger rod.
[96] The drug mixing and injector system of embodiment 88, wherein the
regenerative
energy source is configured to release a portion of energy to drive the second
plunger rod into
the second container and cause a transfer of medicament components in the
second container
to move into the first container, whereby a force is generated on the first
plunger rod, which
in turn causes the vertical rack to rotate the pinion gear assembly, which in
turn causes the
horizontal rack to translate laterally and cause the lever to pivot about the
housing.
[97] The drug mixing and injector system of embodiment 89, wherein the
regenerative
energy source is configured to receive and temporarily store energy when the
lever is
compressed into the housing reversing the mechanical transaction occurring.
[98] The drug mixing and injector system of embodiment 84, wherein the mixing
system
further includes a torsional spring coupled to the horizontal rack, and
wherein the torsional
spring causes the horizontal rack to rack to rotate from a vertical position
when stowed to a
horizontal position that engages with the pinion gear assembly when the lever
is initially
pivoted away from the housing.
[99] The drug mixing and injector system of embodiment 91, whereupon the
horizontal
rack engaging with the pinion gear assembly enables input to the mixing lever
to drive the
pinion gear assembly which in turn drives the vertical rack, which drives the
first plunger rod
into the first container causing the first medicament component to transfer
from the first
17
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
container to the second container to form a mixed medicament with the second
medicament
component.
[100] The drug mixing and injector system of embodiment 83, further including
a sliding
lock that is configured to prevent the lever from pivoting when the sliding
lock is engaged.
[101] The drug mixing and injector system of embodiment 93, further including
a safety cap
removably connected to the housing and configured to cover at least a portion
of the delivery
needle assembly, wherein the safety cap further includes an extension arm
configured to
engage the sliding lock and cause it to translate axially when the safety cap
is removed from
the housing.
[102] A drug mixing system that can be attached to an injector embodiment 95
comprising:
a housing configured to hold a first container and a second container, wherein
the first
container contains a first medicament component and the second container
contains a second
medicament component; a first seal associated with the first container; a
second seal
associated with the second container; a first plunger rod associated with the
first container
that is mechanically connected to a vertical rack that is mechanically driven
by a pinion gear
assembly; a second plunger rod associated with the second container that is
mechanically
connected to a regenerative energy source; a mixing system including a lever
configured to
pivot about the housing; and a fluid communication assembly configured to
receive a first
output from the mixing system, whereupon receiving the first input from the
mixing system
causes the fluid communication assembly to open, remove or otherwise pierce
the first seal
and the second seal and connect a fluid pathway between the first and second
containers.
[103] A drug mixing and injector system embodiment 96 comprising: a housing
configured
to hold a first container and a second container, wherein the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
18
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
container; a first plunger rod associated with the first container; a second
plunger rod
associated with the second container that is mechanically connected to a
regenerative energy
source; a mixing system including a lever configured to pivot about the
housing and
configured to provide input energy to the regenerative energy source; a fluid
communication
assembly configured to receive a first output from the mixing system,
whereupon receiving
the first input from the mixing system causes the fluid communication assembly
to open,
remove or otherwise pierce the first seal and the second seal and connect a
fluid pathway
between the first and second containers; and a needle delivery system
configured to be in
fluid communication with the first and second containers via the fluid
communication
assembly during a delivery phase.
[104] A drug mixing and injector system embodiment 97 comprising: a housing
configured
to hold a first container and a second container, wherein the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
container; a first plunger rod associated with the first container; a second
plunger rod
associated with the second container; a rotary lock disposed about the second
plunger rod; a
mixing system including a lever configured to pivot about the housing; a fluid
communication assembly configured to receive a first output from the mixing
system,
whereupon receiving the first input from the mixing system causes the fluid
communication
assembly to open, remove or otherwise pierce the first seal and the second
seal and connect a
fluid pathway between the first and second containers; and a needle delivery
system
configured to be in fluid communication with the first and second containers
via the fluid
communication assembly during a delivery phase.
[105] A drug mixing and injector system embodiment 98 comprising: a housing
configured
to hold a first container and a second container, wherein the first container
contains a first
19
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
container; a first plunger rod associated with the first container; a second
plunger rod
associated with the second container; a mixing system including a lever
configured to pivot
about the housing; a fluid communication assembly configured to receive a
first output from
the mixing system, whereupon receiving the first input from the mixing system
causes the
fluid communication assembly to open, remove or otherwise pierce the first
seal and the
second seal and connect a fluid pathway between the first and second
containers; and a
needle delivery system configured to be in fluid communication with the first
and second
containers via the fluid communication assembly during a delivery phase.
[106] A drug mixing and injector system embodiment 99 comprising: a housing
configured
to hold a first container and a second container, wherein the first container
contains a first
medicament component and the second container contains a second medicament
component;
a first seal associated with the first container; a second seal associated
with the second
container; a first plunger rod associated with the first container; a second
plunger rod
associated with the second container that is mechanically connected to a
regenerative energy
source; a mixing system including a lever configured to pivot about the
housing and
configured to provide input energy to the regenerative energy source; a fluid
communication
assembly configured to receive a first output from the mixing system,
whereupon receiving
the first input from the mixing system causes the fluid communication assembly
to open,
remove or otherwise pierce the first seal and the second seal and connect a
fluid pathway
between the first and second containers; a sliding lock configured to prevent
the lever from
pivoting during a delivery phase; and a needle delivery system configured to
be in fluid
communication with the first and second containers via the fluid communication
assembly
during a delivery phase.
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[107] These embodiments and others are described in further detail below.
BRIEF DESCRIPTION OF THE DRAWINGS
[108] The foregoing and other objects, features, and advantages of the
invention will be
apparent from the following description of particular embodiments of the
invention; as
illustrated in the accompanying drawings in which like reference characters
refer to the same
parts throughout the different views. The drawings are not necessarily to
scale, emphasis
instead being placed upon illustrating the principles of the invention.
[109] FIGs. 1A-F illustrate various views of a gas-driven reciprocating mixing
and injector
system;
[110] FIG. 1G illustrates a cross-sectional view of the gas-driven
reciprocating mixing and
injector system of FIGs. 1A-F;
[111] FIGs. 2A.1 ¨ 2B.2 illustrate various exposed views of the gas-driven
reciprocating
mixing and injector system demonstrating engaging a fluid communication system
using a
mixing activation mechanism;
[112] FIGs. 2C.1- 2D.2 illustrate various exposed views of the gas-driven
reciprocating
mixing and injector system demonstrating activating the gas chamber using the
mixing
activation mechanism;
[113] FIGs. 3A-B illustrate an alternative gas-driven reciprocating mixing and
injector
system embodiment where the mixing activation mechanism provides multiple
outputs using
a single input;
[114] FIGs. 4A-D illustrate various phases of a mixing trigger of a gas-driven
reciprocating
mixing and injector system;
[115] FIGs. 5A-D illustrate various phases of a multi-directional valve of a
gas-driven
reciprocating mixing and injector system;
21
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[116] FIGs. 6A-E illustrate various states of a gas-driven reciprocating
mixing and injector
system and the transferring of the medicament components between
cartridges/containers;
[117] FIGs. 7A-D illustrate an alternative variation of the various states of
a gas-driven
reciprocating mixing and injector system and the transferring of the
medicament
components between cartridges/containers where the valve stem of the multi-
directional
valve has alternative starting position;
[118] FIGs. 8A-B illustrate various views of one embodiment of a multi-
directional valve
venting locking mechanism for use with a gas-driven reciprocating mixing and
injector
system;
[119] FIGs. 9A-B illustrate various views of an alternative embodiment of a
multi-
directional valve venting locking mechanism for use with a gas-driven
reciprocating mixing
and injector system;
[120] FIGs. 10A-C illustrate various views of an embodiment of an inline hand
compression
reciprocating mixing and injector system;
[121] FIGs. 10D-E illustrate cross-sectional views of the inline hand
compression
reciprocating mixing and injector system of FIGs. 10A-C;
[122] FIG. IOF illustrates removal of a safety/activation release component of
the inline
hand compression reciprocating mixing and injector system of FIGs. 10A-C;
[123] FIGs. 10G-H illustrate the phases of creating fluid communication
between containers
and transferring a medicament from one container to another;
[124] FIGs. 10I-L illustrate various views of releasing the rod sliding lock
from a locking
position to an unlocked position;
[125] FIGs. 10M-Q illustrate various phases of the medicament components from
a ready-
to-mixed phase to a delivered phase including the extension of a needle shield
after the
injection phase;
22
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[126] FIGs. 11A-C illustrate various views of an alternative embodiment of an
inline hand
compression reciprocating mixing and injector system;
[127] FIG. 11D illustrates a cross-sectional perspective view of the inline
hand compression
reciprocating mixing and injector system of FIGs. 11A-C;
[128] FIG. 11E illustrates removal of a safety/activation release component of
the inline
hand compression reciprocating mixing and injector system of FIGs. 11A-C;
[129] FIGs. 11F-G illustrate the phases of creating fluid communication
between
containers;
[130] FIGs. 11H-I illustrate various views of releasing the rod sliding lock
from a locking
position to an unlocked position;
[131] FIGs. 11J-K illustrate various transfer states between containers once
the spring-
driven plunger rod is activated;
[132] FIGs. 11L-N illustrate various phases of the inline hand compression
reciprocating
mixing and injector system of FIGs. 11A-C preparing to deliver and delivering
a mixed
medicament;
[133] FIGs. 12A-B illustrate various views of an alternative embodiment of a
compression
lever reciprocating mixing and injector system using a rack and pinion system;
[134] FIG. 12C illustrates a cross-sectional view of the compression lever
reciprocating
mixing and injector system using a rack and pinion system of FIGs. 12-B;
[135] FIGs. 12D-F illustrate various views of the compression lever
reciprocating mixing
and injector system in a stowed state;
[136] FIGs. 12F-H illustrate various views demonstrating creating fluid
communication
between the containers and activating the reciprocating mixing system;
[137] FIGs. 12I-L illustrate various views of one embodiment of the horizontal
rack
components for use with the compression lever reciprocating mixing and
injector system;
23
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[138] FIGs. 12M-P illustrate various views of an alternative embodiment of the
horizontal
rack components for use with the compression lever reciprocating mixing and
injector
system;
[139] FIGs. 12Q-T illustrate various views and states of a rotary rod lock for
use with a
reciprocating mixing and injector system;
[140] FIGs. 12U-W illustrate various views demonstrating rotating the rotary
rod lock and
releasing the plunger rod associated with the constant force spring;
[141] FIGs. 12X-AA illustrate various views demonstrating various phases of
the
medicament components from a ready-to-mixed phase to a ready-to-be delivered
phase;
[142] FIGs. 12BB-GG illustrate various views demonstrating initiating the
mixing lever
sliding lock prior to delivering the mixed medicament components.
DETAILED DESCRIPTION OF THE INVENTION
[143] To provide clarity, the applicants would like to provide context around
certain terms
used throughout this description that is in addition to their ordinary
meaning.
[144] Distal or distal end primarily refers to the end of the mixing and
injector system
having the components and features to drive the plungers. In contrast,
proximal or proximal
end refers to the end of the device where the plungers are being driven into.
For example, in
all of the embodiments disclosed the delivery needle is disposed on the
proximal end of the
mixing and injector systems. Additionally, the distal end of the delivery
needle is the end
that is receiving the mixed medicament components, whereas the proximal end of
the
delivery needle is injecting the mixed medicament components into a recipient
or otherwise
releasing the mixed medicament components.
24
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[145] For purposes of this application the term container can include any
component that is
configured to hold a volume. For example, a cartridge, pre-filled syringe, a
vial and so forth
would be considered a container. Containers can have attachment points,
removable or
pierceable seals associated with them and have medicament components stored
therein.
[146] As noted, there is a need to improve upon drug mixing devices to allow
for drug
formulations where high-intensity and/or long duration mixing is needed after
combination
of the drug constituents. The inventors, who created the embodiments herein,
have provided
solutions to at least this noted problem as well as other problems that will
become apparent
upon reading this description.
[147] In many of the embodiments provided herein there is provided a fluid
communication
system, that includes a pair of mixing needles, a fluidic channel and a frame.
This system
can be positioned in the housing in a fixed manner, where other systems engage
into it, or it
can movable in a distal and/or proximal manner to engage with the containers
as well as
needle delivery system. Greater detail and examples of this fluid
communication system can
be found in U.S. published application U52022/0001112 Al.
[148] Now referring to the specific embodiments, FIGs. 1A-F illustrate various
views of a
gas-driven reciprocating mixing and injector system 100. FIG. lA is a
perspective view of
100 illustrating the housing 102, the mixing activation mechanism housing 106,
housing
aperture 108, mixing trigger 120, venting lockout mechanism 130, and safety
cap 140. These
features can also be seen in the front and back views in FIGs. 1B-C, in the
top and bottom
views of FIGs. 1D-E, and the side view of 100 in FIG 1F.
[149] Additional components of the gas-driven reciprocating mixing and
injector system
100 are illustrated in the cross-sectional view shown in FIG. 1G. A
pressurized gas chamber
110 is situated in a gas chamber housing 111 and is initially separated from a
gas piercing
and gas/fluid communication member 112, which upon piercing provides gas/fluid
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
communication to a gas regulator 113, which is configured to control the
amount the
pressure of the gas exiting the regulator 113 into the mixing system 170. A
multi-directional
valve 172 is part of the mixing system 170, which is configured to receive the
controlled
pressurized gas and redirect according to the positioning of the multi-
directional valve.
Further detail of the valve 172 will be provided in more detail below. The
valve 172
interfaces with two gas-driven plungers 174A-B that are disposed within first
and second
containers 164A-B, each containing a first or second medicament component 181A-
B
(shown in FIG. 6A), which are initially separated from each other during the
stowed state of
the system 100.
[150] A fluid communication assembly 150 is positioned proximally to the
containers
164A-B. It should be noted the first and second containers can be disposed
within a cartridge
container frame or housing 160. The fluid communication assembly 150 is
comprised of a
pair of mixing needles 154, a fluid communication channel 156, a frame (not
labeled), and in
this particular embodiment a fluid communication assembly tab 152 (illustrated
in FIG.
2A.1).
[151] The safety cap 140 covers the needle shield assembly 190, as well as the
delivery
needle 192.
[152] FIGs. 2A.1 ¨ 2B.2 illustrate various exposed views of the gas-driven
reciprocating
mixing and injector system 100 demonstrating engaging the fluid communication
assembly
150 using the mixing activation mechanism, which includes the mixing
activation
mechanism housing 106. The mixing activation mechanism housing 106 is in
mechanical
communication with a mixing activation slide 114, which includes a ramped
protrusion 115
positioned above a sliding base. A mixing activation strap 117 has a strap
flange portion 119
that interfaces with the base of the mixing activation slide 114, until it is
drawn up the ramp
115 portion of 114, by sliding or pulling 114 linearly, such that ramp 115
engages flange
26
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
119. On the other end of strap 117 is a strap connection interface 118 that
mechanically
interfaces and attaches to the fluid communication system tab 152. As 117
moves upwards,
or in a distal manner, it pulls on 152, which forces 150, and in particular
the mixing needles
154, to engage with the first and second containers 164A-B, pierce the seals
about each
container, and create fluid communication between the two containers.
[153] In order to linearly move the mixing activation slide 114, the mixing
activation
mechanism housing 106, which includes a mixing activation mechanism flange
107, which
is configured to engage the mixing activation slide flange 116 of 114, can be
pulled away
from housing 102 by a user. This pulling causes 106 to pull 114, which then
causes strap
117 to move distally causing 150 to create fluid communication. Arrows shown
in FIGs.
2B.1-B.2 show the lateral movement, which leads to the upward or distal
movement.
[154] Continuing to the next phase, FIGs. 2C.1- 2D.2 illustrate various
exposed views of the
gas-driven reciprocating mixing and injector system 100 demonstrating
activating the gas
chamber 110 using the mixing activation mechanism, which includes the mixing
activation
mechanism housing 106. Here instead linearly pulling 106, the user now rotates
106, which
ultimately causes the gas chamber 110 to be pierced by the gas piercing and
gas/fluid
communication member 112, that creates gas/fluid communication with the
regulator 113.
As the user rotates 106, screws on the gas chamber housing 111 engage with the
subframe
103 that is disposed within housing, and pushes the gas chamber 110 into 112.
It should be
noted that one end of the gas chamber housing is hexagonal shape that is keyed
or fitted to a
complementary internal hexagonal shaped sidewall of 106. Thus, the user is
able to pull 106
linearly without engaging 111, until the user rotates 106. The complementary
shapes of the
gas chamber and the activation mechanism housing can be a variety of shapes,
such as
square, octagonal, pentagon, and so forth. The hexagonal shape should not be
construed to
be a limiting shape.
27
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[155] FIGs. 3A-B illustrate an alternative gas-driven reciprocating mixing and
injector
system embodiment 100A where the mixing activation mechanism, includes an
alternative
mixing activation mechanism housing 106A that is configured to provide
multiple outputs
using a single input or user motion. Here instead of pulling 106A in a linear
manner, a user
simply rotates 106A, which causes the two outcomes of fluid communication
between
containers 164A/B and mixing needles 154 while subsequently piercing the gas
chamber.
Similar to the above embodiment, 100A also includes a mixing activation slide
114A that
interfaces with a mixing activation strap 117A in similar fashion, which as
114A is moved
linearly, 117A is forced upwards or distally up the ramp 115A of 114A, which
causes the
fluid communication assembly 150 to engage the first and second containers and
create fluid
communication. To cause the linear motion of 114A, the user rotates 106A,
which in this
version includes threaded screws 104A that engage with screw channels 109A of
114A that
are positioned on the back side or internal side of 114A, which is viewable
from FIG. 3B.
Once 117A is forced to the top of ramp 115A it becomes slotted in notch or
channel 105A of
subframe 103A, a flange 116A of 114A engages with a surface of 103A to prevent
further
linear motion. The user is allowed to continue rotating 106A, which continues
to use the
screw channels 109A of 114A to move 106A further into housing 102. A gas
chamber 110A
disposed within 106A, similar as to the above embodiment (but not shown), is
then pressed
into a piercing and gas/fluid communication member (again similar to 112
above, but not
shown) until the gas chamber is pierced and fluid communication with the
regulator of 100A
occurs, which pressurizes the regulator and mixing system. The regulator of
100A is the
same or similar to regulator 113 of system 100.
[156] Once gas/fluid communication occurs and the regulator and mixing systems
are
pressurized, the user can now utilize the mixing trigger 120 to transfer fluid
back and forth
between the first and second containers. FIGs. 4A-D illustrate various phases
of mixing
28
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
trigger 120, which can be used with either system 100 or 100A. In the
embodiment shown in
FIGs. 4A-D, there is include a valve stem release slide 122. This release
slide 122 initially
keeps the valve stem 173 of valve 172 in a depressed state. When a user
initial depresses
mixing trigger 120, a mixing trigger angled interface 121 interfaces with a
valve stem
release slide angled interface 123 and forces release slide 122 upwards or in
a distal manner,
which then enables the valve stem to be released. Once the user releases
pressure from
mixing trigger 120, neither the release slide nor the mixing trigger are
impeding valve stem
173 allowing it to protrude or extend outwards from the valve 172 as shown in
FIG. 4C.
When the user depressed the mixing trigger 120 again, it also depresses the
valve stem 173,
which as will be described further below changes the position of the internal
pathways of the
valve 172, thus redirecting pressurized gas received from the regulator and
gas chamber in a
particular manner. The valve stem 173 has a valve spring 171 that interfaces
with it and
forces the valve stem outwards, when it is not being depressed or otherwise
impeded.
[157] FIGs. 5A-D illustrate various phases of a multi-directional valve of a
gas-driven
reciprocating mixing and injector system 100 or 100A and the paths of
pressurized gas. It
should be understood that FIGs. 5A-D illustrate a valve 172 and phases based
on the valve
stem initially being in a blocked or depressed state. For example, if the
system 100 or 100A
included release slide 122. However, it should be noted that release slide 122
is optional, and
the valve 172 could initially be in a position where the valve stem 173 is
extended. This will
be explored further in FIGs. 7A-D.
[158] Referring now to FIG. 5A, where valve 172 is in a stowed state. There is
no
pressurized gas being directed into the valve via valve inlet 175 or directed
out of gas
plunger egress 177A or 177B. Pressurized gas is also not being directed out of
venting ports
176A or 176B. When the system 100 or 100a is initially pressurized by piercing
the gas
chamber, the regulator sends pressurized gas into the valve inlet 175. The
incoming path of
29
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
gas 178A initially comes in through 175 and out of 177A to drive plunger 174A
downwards.
This initial pressurization also causes an initial transfer of the first
medicament component
181A in the first container 164A to be transferred via 150 into the second
container 164B,
where it begins mixing with the second medicament component 181B to form a
mixed
medicament component 182. Once the mixing trigger 120, and thus the valve stem
173, is
released, the incoming path of gas 178A is altered to where pressurized gas is
now directed
into 175 and out through 177B to drive the second plunger 174B of the second
container
164B. The mixed medicament 182, currently in the second container, is now
driven out of
the second container and into the first container, where it pushes upwards or
distally on the
first plunger 174A. Gas that originally was pressing down on the first plunger
is able to
escape through vent port 176A as shown by the outgoing path of gas 178B shown
in FIG.
5C. The mixing trigger 120, and thus the valve stem 173, can be depressed
again, which
alters the incoming gas path 178A to push down on the first plunger, which
causes the
mixing medicament 182 currently in the first container to transfer to the
second container,
force the second plunger upwards, where gas previously driving the second
plunger
downwards is now vented through vent port 176B as shown by the redirected
outgoing path
of gas 178B in FIG. 5D. At this point, those skilled in the art, can readily
ascertain that the
user can continue to depress and release the mixing trigger 120, which
depresses and
releases the valve stem 173, which alternates the gas paths going in and out,
thus forcing the
first and second plungers to be driven downwards (proximally) or upwards
(distally) that in
turn transfers the mixed medicament back and forth between the first and
second containers
as many times as the user decides. Each transfer back and forth helps to
further mix or blend
the medicaments components together as noted above, which is one of the
problems to be
solved because certain medicament components require additional or extra
mixing energy to
achieve a high-quality mixed medicament. In many cases, the mixing time itself
can be
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
reduced when compared to mixing that is achieved by simple shaking or swirling
of the
combined medicament components. It can readily be seen that using one of the
systems of
100 or 100A, a user could easily depress the mixing trigger, 10, 20, 30, 40 or
more times
resulting in 20, 40, 60, 80 or more transfers between the first and second
containers. The
user can then check through housing aperture 108 to confirm the medicament
looks fully
mixed. An additional benefit of 100 and 100A is that the mixing can be
deterministic and
directly connected to the number of mixing cycles as a determination of
completeness, rather
than subjective determinations of mixing completeness, like visual inspection
alone.
[159] FIGs. 6A-E illustrate and provide additional clarity to the various
states of a gas-
driven reciprocating mixing and injector system 100 or 100A and the
transferring of the
medicament components between containers. FIGs. 6A-E show the interface
between the
valve 172, first and second containers 164A-B, and the fluid communication
assembly 150.
FIG. 6A illustrates a stowed state where no pressurized gas is acting on
either of the first or
second plungers 174A-B. Once pressurized, as shown in FIG. 6B, the first
plunger 174A is
driven into the first container and medicament component 181A is combined with
medicament component 181B in the second container 164B to form mixed
medicament 182.
The valve stem 173 is release and the mixed medicament 182 is transferred from
container
164B into 164A. The incoming and outgoing paths of gas 178A-B alternate as the
valve
stem 173 causes the alteration within valve 172. In Fig. 6D the user depresses
the mixing
trigger 120, which depresses the valve stem 173 and the transfer from first
container to
container of 183 occurs. Once a user is satisfied that mixed medicament 182 is
fully mixed
or homogenized, they can then proceed to the next phase, which is to lock out
one or more
venting ports (176A and/or 176B). Further details on how this is done are
provided below.
Once one or more ports art blocked and the delivery needle assembly is in
fluid
communication with the fluid communication assembly 150, the next release (as
in this case)
31
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
as shown in FIG. 6E causes the pressurized gas to force the mixed medicament
out of the
second container through the delivery needle into a recipient. It should be
noted, that the
system can prepared for the delivery state with either a release or a
depression of the mixing
trigger 120, prior to engaging the venting lockout mechanism, once the user is
satisfied the
drug product is properly mixed.
[160] FIGs. 7A-D illustrate an alternative variation of the various states of
a gas-driven
reciprocating mixing and injector system and the transferring of the
medicament
components between containers where the valve stem 173 of the multi-
directional valve 172
has an alternative starting position. As shown in FIG. 7A, the valve stem 173
is extended
during the stowed stated, thus when the system is pressurized, as in FIG. 7B,
the system
pressurization causes the first transfer of medicament 181A in container 164B
to go into
164A and mix forming mixed medicament 182. The user's first action on the
mixing trigger
120 is a depression, which causes a second transfer or in other words the
mixed medicament
182 to transfer from container 164A into 164B. If venting port 179A were to be
blocked at
this moment, when the user releases the mixing trigger, and thus releasing the
valve stem
173, the mixed medicament 182 would then travel out of the container 164B
through the
delivery needle into a recipient, so long as the delivery needle is in fluid
communication
with fluid communication assembly 150. If not, then the mixed medicament would
remain in
the container 164B (and not transfer into 164A) until the delivery needle
comes in fluid
con-nnunication with fluid communication assembly 150.
[161] It should be noted that the mixed medicament's final position could be
in either
container (164A-B) and either a release or depression on the mixing trigger
could release the
mixed medicament. It should also be noted, that although medicament component
181A is
shown as a liquid it could also be a dry component, and vice-versa where
medicament
component 181B shown as a dry component, could also be a liquid component. It
is
32
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
generally desirable to have the first medicament component being transferred
to be liquid,
but not an absolute requirement. It is possible for both medicament components
to be
liquids. One of the advantages of the systems already described are that
medicament
components with varying viscosities, miscibility, compactness of powders and
so forth can
still be readily combined in these systems and on demand as needed in fairly
quick and
consistent manner.
[162] As just noted, it is important to block one or more of the venting ports
of the valve
172 prior to delivering the mixed medicament. The embodiments shown in FIGs.
8A-B and
9A-B illustrate at least two versions of accomplishing the blocking of the
venting ports.
These are meant to be exemplary and not limiting, which is the intention of
providing at
least two examples. Now referring to the embodiment shown in FIGs. 8A-B, this
is a vent
obstruction method and system configured to block a single venting port, such
as 176A.
When the user depresses venting locking mechanism 130, it interfaces with a
camming arm
131 that forces a vent obstruction component 179A down over (and in some cases
into)
venting port 176A. When using a single vent port obstruction system, it is
important for the
valve to be aligned in the appropriate position. In this case, the user would
depress the
mixing trigger 120 and while holding the mixing trigger 120 also depress
venting locking
mechanism 130. Thus, this ensures that the mixed medicament is leaving
container 164B,
such as shown in FIG. 6E and not returning to container 164A.
[163] An alternative vent obstruction system is shown FIGs. 9A-B and is more
agnostic to
which container has the mixed medicament in it prior to delivery. This is
because in this
embodiment, venting lockout mechanism 130A is a sliding mechanism that has two
ramped
protrusions 132 that when slid over vent obstruction components 179A and 179B
forces
both of the vents 176A and 176B to be closed. In the variation shown, 130A is
pushed into
33
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
the housing, but it should readily be recognized that a version where the user
pulls 130A out
of the housing while accomplishing the purpose of both vents being obstructed.
[164] In order to dispense the mixed medicament 182, the needle shield
assembly 190 is
depressed on the injection site, thus pushing the needle delivery assembly
197, along with
the delivery needle 192, into the delivery septum 196 creating fluid
communication between
the delivery needle 192 and the fluid channel 156. The piercing of the
delivery septum 196
causes the previously pressurized container containing mixed medicament 182 to
be forced
through delivery needle 192.
[165] For additional context on how the needle shield assembly 190 and
delivery needle 192
function and interface with the fluid communication system, the inventors
refer to the
published patent application noted above as well as some of the embodiments to
be shown
below. One of the primary focuses of the systems 100 and 100A is to convey an
improved
reciprocating mixing and injector system capable of mixing difficult to mix
medicament
components.
[166] The remaining embodiments provided below include reciprocating mixing
and
injector systems that utilize various springs and mechanisms for the back-and-
forth transfer
of medicament components from one container to another container.
[167] One such example is shown in FIGs. 10A-C which illustrate various views
of an
embodiment of an inline hand compression reciprocating mixing and injector
system 200.
System 200 is comprised of a housing 202, having an aperture 208, a
safety/activation
release 206, a needle shield assembly 290 and mixing grips 220 and 221, where
mixing grip
220 is a movable mixing grip and 221 is a stationary or non-moving mixing
grip.
[168] FIGs. 10D-E illustrate cross-sectional views of the inline hand
compression
reciprocating mixing and injector system 200 of FIGs. 10A-C in a perspective
cross-
sectional view (10D) and side cross-sectional view (10E) to further illustrate
the several
34
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
components that enable this embodiment to store, mix and deliver a mixed
medicament
component 282 formed of first and second medicament components 281A-B. A
constant
force spring 210 is associated with a plunger rod 280B, whereas plunger rod
280A is directly
coupled to mixing grip 220. Situated below each of the plunger rods are
plungers 274A-B
each disposed in one of containers 264A-B, each which hold a medicament
component
181A-B. Similar to the gas-powered embodiments, containers 264A-B are held in
place
using a cartridge container frame 260, which can be driven into the fluid
communication
assembly 250 having mixing needles 254 and fluid communication channel 256. A
needle
shield assembly 290 is configure to be initially compressed during a delivery
phase to
expose the delivery needle 292, but then become fixed into place thereafter to
prevent
accidental future injuries from the sharp delivery needle 292.
[169] FIG. 1OF illustrates the removal of a safety/activation release 206
component of the
inline hand compression reciprocating mixing and injector system 200, which
allows the
mixing grips 220 and 221 to be compressed together by a user's hand.
[170] FIGs. 10G-H illustrate the phases of creating fluid communication
between containers
264A-B and transferring a first medicament component 281A from one container
to another
to begin mixing with a second medicament component 281B to form a mixed
medicament
282. When system 200 is in a stowed state there is no fluid communication
between the
containers. Once safety 206 is removed, the user can begin to compressing the
mixing grips.
Mixing grip 220, which is directly coupled to plunger rod 280A engages plunger
274A. As a
result of medicament component 281A being a fluid, which most fluids are
incompressible,
the force is transferred to the cartridge container frame 260, which forces
both containers
onto the fluid communication assembly 250, where the mixing needles 254 pierce
into each
container and create a fluid communication pathway between each container. As
the user
continues to press further downward, the plunger rod 280A can now act further
on plunger
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
274A to force the liquid medicament component 281A out of container 264A
through 250
into container 264B.
[171] FIGs. 10I-L illustrate various views of releasing the rod sliding lock
212 from a
locking position to an unlocked position, so that the constant force spring
210 can act on
driving plunger rod 280A downward or proximally. Another action that occurs
when the
user first compresses the mixing grips, is as the travel of the mixing grip
goes far enough, a
sliding lock engagement flange 214 of 220 interfaces with a ramped portion of
rod sliding
lock 212 and causes 212 to move in an orthogonal or lateral direction with
respect to the up
and down direction of the mixing grips and plunger rods. This lateral shifting
releases a
notched portion 213 on plunger 280B from engaging with a ledge of 212 and
preventing
plunger rod 280B from traveling downward. Once released, as the user begins to
decompress or release their grip on the mixing grips 220 and 221, the constant
force spring
210 can now drive the plunger rod 280B downward, which forces mixed medicament
in
264B back into container 264A and forces the plunger rod 280A upwards.
[1721 The reciprocating back and forth transfer between containers and
ultimate delivery of
the mixed medicaments is further shown in FIGs. 10M-Q, which illustrate these
various
phases of from a ready-to-mixed phase to a delivered phase including the
extension of a
needle shield after the injection phase. FIG. 10M illustrates the phase where
the rod sliding
lock 212 has been released the constant force spring 210 has driven plunger
rod 280B down,
which has caused plunger rod 280A to go up as just noted. The mixed medicament
component 282 is now in container 264A. The user can now compress mixing grips
as many
times as necessary, such as shown in FIG. 10N, to continuously transfer the
mixed
medicament 282 back and forth between containers until they are satisfied
mixing of the
medicament is sufficient, which can be supported by viewing the mixed
medicament
through the aperture 208 or referencing a predetermined number of counts
and/or mixing
36
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
cycles. With each release of the mixing grips the constant force spring 210
transfers the
mixed medicament component back to container 264A.
[173] When the user is ready to deliver the mixed medicament 282, the user
while
compressing the mixing grips, can depress the needle shield assembly 290 over
the injection
site, which upon being initially depressed, compresses and uncovers the
delivery needle 292.
When the delivery needle is further depressed or injected into a recipient, it
causes the distal
end of the delivery needle to pierce a delivery septum 296 that creates fluid
communication
with fluid communication assembly 250. Once the fluid communication is
created, the
constant force spring 210, which is continually acting on plunger rod 280B,
can now drive
the mixed medicament 282, which is now in container 264B, as a result of
compressing the
mixing grips, into the recipient through the delivery needle 292. When the
user pulls the
needle out of the recipient, a spring in the needle shield assembly causes it
to extend and
lock in to place as shown in FIG. 10Q.
[174] FIGs. 11A-C illustrate various views of an alternative embodiment of an
inline hand
compression reciprocating mixing and injector system 300. System 300 is
comprised of a
housing 302, a safety/activation release pin 306, a needle delivery assembly
397, a needle
sheath 394, and mixing grips 320 and 321, where mixing grip 320 is a movable
mixing grip
and 321 is a stationary or non-moving mixing grip.
[175] FIG. 11D illustrates a cross-sectional perspective view of the inline
hand compression
reciprocating mixing and injector system 300. Connecting posts 307 directly
couple the
movable mixing grip 320 to the plunger rod 380A. The safety pin 306 interferes
with one of
the connecting posts 307 to prevent it from moving until the pin 306 is
removed. A
compressing spring 310 acts on plunger rod 380B. Plungers 374A-B are
respectively
disposed below plunger rods 380A-B and disposed respectively in containers
364A-B,
which are held in place by cartridge container frame 360. A fluid
communication assembly
37
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
350 having mixing needles 354 and a fluid communication channel 356 is
situated below
360 and is initially in a non-fluid communication state during storage. A
needle assembly
397 is positioned below 350 and is also configure to be initially in a non-
fluid
communication state until compressed during the delivery phase. A needle
sheath 394 is
disposed over the delivery needle 392 until being removed for injecting.
[176] FIG. 11E illustrates the removal of a safety/activation release pin 306
of the inline
hand compression reciprocating mixing and injector system 300, which enables
the mixing
grip 320 to be compressed into mixing grip 321. Similar to system 200, and as
shown in
FIGs. 11F-G, when the user initially compresses grips 320 and 321 together,
the directly
coupling of grip 321 to the plunger rod 380A cause the plunger rod to push on
the plunger
374A, which compresses against the liquid medicament component 381A in the
first
container 364A. As a result of the incompressible nature of most fluids, the
force acts on the
cartridge container frame 360 to drive the first and second containers 364A-B
into the fluid
communication assembly 350 and particularly into the mixing needles 354 to
create a fluidic
flow path between the first and second containers. Once the flow path is
established, the
continuing compression force imparted onto the mixing grips causes the
medicament
component 381A into the second container 364B to mix with medicament component
381B
and form a mixed medicament 382.
[177] In order to release the stored energy in the compression spring 310, the
rod sliding
lock 312 needs to laterally shifted or transitioned. This transition is
illustrated in FIGs. 11H-
I. A sliding lock engagement flange 314 is positioned along a portion of
plunger rod 380A
and when it has traveled sufficiently engages with a ramped portion of the rod
sliding lock
312, which downward force on the ramp generates a lateral movement or shifting
in 312.
These shifting releases the notched portion 313 of plunger rod 380B from a
ledge portion of
312 to be released and freely travel. One of the advantages of these rod
sliding locks 212,
38
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
312 is that with each compression of the mixing grips ensures the plunger rods
280B, 380B
are free to move. Once the rod sliding lock 312 is out of an interference
position, the
compression spring 310 can now act to drive the plunger rod 380B onto plunger
374B and
transfer the mixed medicament from container 364B into container 364A.
[178] FIGs. 11J-K illustrate various transfer states between containers once
the spring-
driven plunger rod 380B is activated and the compression spring 310 free to
drive it. Similar
to system 200, with each compression there is a transfer and with each release
there is a
transfer of mixed medicament.
[179] When sufficient mixing has occurred, the user can prepare the device to
deliver the
mixed medicament 382, such as shown in FIGs. 11L-N which illustrate various
phases of
preparing the inline hand compression reciprocating mixing and injector system
300 to
deliver and delivering a mixed medicament. The sheath 394 can be removed as
shown in
FIG. 11L. The user while compressing the grips, can inject the exposed
delivery needle into
an injection site. This injecting causes a pressure on the needle 392 and the
needle assembly
390, which moves upward or distally into the fluid communication assembly 350
and pierces
the delivery septum 396. Once that is accomplished the compression spring 310
drives
plunger 380B to force the mixed medicament now in container 364B out of the
system
through the delivery into the recipient.
[180] FIGs. 12A-B illustrate various views of yet another alternative
embodiment of a
reciprocating mixing and injector system 400 using compression lever with a
rack and
pinion system. System 400 includes a housing 402 having an aperture 408, a
lever 420,
pivoting about a pivot pin 421, and a safety cap 440.
[181] FIG. 12C illustrates a cross-sectional view of the compression lever
reciprocating
mixing and injector system 400 to further illustrate the several components
that enable this
embodiment to store, mix and deliver a mixed medicament component 482 formed
of first
39
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
and second medicament components 481A-B. These include a constant force spring
410
configured to drive plunger rod 480B that drives plunger 474B into container
464B. The
lever 420 has a horizontal rack 414 connected thereto that interfaces with a
pinion gear 415,
which is configured to drive a vertical rack 413 that is directly coupled to a
plunger rod
480A that can drive a plunger 474A into container 464A. The containers 464A-B
are
disposed within a cartridge container frame 460. A fluid communication
assembly 450 is
configured to be driven up or distally into the containers 464A-B to create
fluid
communication between each container and is comprised of mixing needles 454
and a
fluidic communication channel 456. A needle shield assembly 490 is disposed
over a
delivery needle 492.
[182] FIGs. 12D-E illustrate various partial cutaway and cross-sectional views
of the system
400 in a stowed state. As shown, in FIG. 12D, the horizontal rack 414 is
initially stored in an
upright manner having its lower leg portion 416 resting on pinion gear, but
not engaged with
pinion gear 415. Also shown is a fluid communication assembly protrusion 452
that
interfaces with a camming edge 422 of lever 420. When the lever 420 is
initially extended
away from the housing 402, the horizontal rack 414 drops down and engages the
pinion gear
415 and the camming edge 422 applies an upward or distal force on the
protrusion 452,
which causes the fluid communication assembly 450 to move upwards or distally
into the
containers 464A-B, where the mixing needles 454 pierce seals on the containers
and create
fluid communication between the two containers 464A-B. FIG. 12E illustrates a
closer view
of the fluid communication assembly 450 prior to engaging the containers 464A-
B. Also
labeled in FIG. 12E are the delivery septum 496 which separates fluid
communication with
the delivery needle 492 until the distal end of the delivery needle pierces
the septum and
comes in fluid communication with fluidic channel 456.
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
[183] FIGs. 12F-H illustrate various views demonstrating creating fluid
communication
between the containers and activating the reciprocating mixing system, as it
illustrates
camming edge 422 forcing protrusion 452 upwards or distally as just noted.
Horizontal rack
414 has rotated downward so that the teeth of horizontal rack 414 engage the
teeth of pinion
gear 415. FIG. 12H specifically illustrates a close-up view of fluid
communication assembly
450 engaging with the containers.
[184] FIGs. 12I-L illustrate various views of one embodiment of the horizontal
rack
components for use with the compression lever reciprocating mixing and
injector system
400. In this embodiment, 414 is shown in FIG. 121 in an upright position
during a stowed
state. When the lever 420 is extended or pivoted away from housing 420, the
lower leg
portion 416 is allowed to rotate off of pinion gear 415 and the combination
torsional and
compression springs 417 further force horizontal rack 414 to rotate downward
or
proximally. The horizonal racks 416 rotate about a rack mounting pin 424 that
is disposed
through an alignment aperture 419 of each horizontal rack 414, sidewalls of
420 and the rack
alignment and mounting protrusion 423. Once the horizontal racks have rotated
to engage
the pinion gear, the springs 417 push each of the horizontal racks 414 toward
the protrusion
423, which includes a ledge 425 on each side that interfaces with a
complementary ledge
418 of horizontal rack 416 to prevent the horizontal racks from rotating
upward. This acts as
a secondary mechanism to ensure the horizontal rack has a constant engagement
with the
pinion gear regardless of orientation.
[185] FIGs. 12M-P illustrate various views of an alternative embodiment of the
horizontal
rack 414A components for use with the lever 420 of the reciprocating mixing
and injector
system 400. The primary differences between 414 and 414A are that 414A
includes a spring
post 426A that is configured to have a compression spring 427 attached
thereto. With the
414A embodiment, a torsional spring 417 still helps rotate the horizontal rack
414A, but the
41
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
compression spring 427A is what pulls the horizontal racks together to mount
and interface
with the rack alignment and mounting protrusion 423 Aside from the spring post
426A and
compression spring 427A, the two variations of horizontal racks 414 and 414A
operate in
the same manner.
[186] FIGs. 12Q-T illustrate various views and states of a rotary rod lock 412
for use with
the reciprocating mixing and injector system 400. The rotary rod lock 412
prevents plunger
rod 480B from traveling downward or proximally when the rotary rod lock 412 is
in a
locked position. The constant force spring 410 is mounted to the arms 411 of
plunger rod
480B on one end and is grounded or fixed to the housing 402 on the opposite
end. This
spring 412 is constantly providing a downward force onto the plunger rod 480B.
FIG. 12R
isolates plunger rod 480B and shows a keyed slot 484 and keyed slot ledge 485.
It is this
keyed slot edge 485 that rests on the rotary lock key 486 of rotary rod lock
412, as shown in
FIG. 12S until it is rotated away that the ledge 485 falls off the key 486, as
show in FIG.
12T and the rotary lock key 486 is now aligned with the keyed slot 484 to
freely move
vertically up and down or distally and proximally in the system 400.
[187] FIGs. 12U-W illustrate various views demonstrating how to rotate and
unlock the
rotary rod lock to release the plunger rod 480B. After the lever 420 is
extended and the
horizontal racks 414 drop to engage the pinion gear 415, the lever 420 can be
compressed.
This compression now transfers a force from the horizontal racks into the
pinion gear 415,
which drives the vertical rack 413 to also drive the plunger rod 480A it is
directly coupled
to. By driving the plunger 480A downward it causes the medicament component
481A
currently in container 464A to transfer over into container 464B, to then mix
with the
medicament component 481B to form mixed medicament 482. As this is occurring
the
horizontal racks 414 are extending into the housing and interfacing with the
rotary rod lock
412. As shown in the partially isolated components view in FIG. 12U the rotary
lock
42
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
protrusion 487 of rotary rod lock 412 is offset such that one of the 414 racks
are able to
engage it and cause 412 to rotate into a position as shown in FIG. 12V. At
this position in
FIG. 12V the key 486 moves into the keyed slot and out from under the ledge
485, which
enables the plunger rod 480B to move up and down vertically. Now that the
constant force
spring can further act on 480B, when the user releases the lever 410, the
constant force
spring 420 drives the plunger 480B downward to engage plunger 474B, which
drives the
mixed medicament 482 in 464B through the fluid communication assembly 450 into
container 464A, which causes plunger 474A to push upwards on plunger rod 480A,
which is
coupled to vertical rack 413, that now causes pinion gear 415 to rotate in a
manner that puts
a force on horizontal racks 414 to push lever 410 away from the housing 402.
Now the
reciprocating medicament transfer system is fully operational, such that with
each
compression of the lever 420 transfer is made from one container to the other,
and with each
release of the lever the constant force spring causes a transfer back from
container 4648 into
464A.
[1881 This transferring medicament between containers is further illustrated
in FIGs. 12X-
AA, which illustrate various views demonstrating the various phases or
positions of the
medicament components are in from a ready-to-mix phase to a ready-to-be
delivered phase.
FIG. 12 X illustrates the ready-to-mix phase or state of system 400. Here, as
noted above,
the lever 420 has been extended, which creates fluid communication between the
containers
464A-B, and also creates a mechanical engagement of lever 420 via horizontal
racks 414
with the pinion gear 415. When the user then compresses the lever 420 for the
first time,
energy is transferred into the system that drives the plunger rod 480A
downward, also as
noted above, which causes the plunger 474A to transfer the medicament
component 481A to
transfer into container 464B and become mixed with medicament component 481B
to form
mixed medicament 482, as shown in FIG. 12Y. At this point the rotary rod lock
412 has
43
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
released plunger rod 480B. When the user releases their grip on lever 420 the
constant force
spring 410 now drives plunger rod 480B downward, also as noted above, which
transfers the
mixed medicament 482 from container 464B into container 464A, as shown in FIG.
12Z.
The user can then compress the lever 420 again where mixed medicament 482 is
transferred
back into container 464B, as shown in FIG. 12AA. This transferring back and
forth can
continue until the user is satisfied the mixed medicament has been thoroughly
mixed or
blended, which can be in part determined by viewing the medicament through the
housing
aperture 408 or some predetermined number of counts.
[189] Once the user is ready to deliver the medicament they can lock the lever
420 in place.
This is illustrated in FIGs. 12BB-GG demonstrating the elements and
configurations that
enable 420 to be locked into place prior to delivering the mixed medicament. A
partial
isolated view of various components is shown in FIGs. 12BB-CC, which shows
when the
sliding lock 445 is in an upward or distal position that the lever 420 is
allowed to pivot about
pivoting pin 421 and sliding 445 doesn't interfere with that pivoting. FIG.
12DD shows an
isolated parts perspective view to show how an extension arm 441 of the safety
cap 440
engages with the sliding lock 445.
[190] As the safety cap 440 is pulled off or away from the housing 402, the
extension arm
441 pulls down the sliding lock 445 through the extension clip 442 and sliding
lock notch
446 interface. The extension clip 442 rests in the sliding lock notch 446 of
445 as it is
sandwiched between 445 and a protrusion 491 extending from the needle shield
assembly
490. This sandwiching prevents the extension clip 442 from being released from
the sliding
lock notch 446. However, as the safety cap is pull off it pulls the notch 446
past the
protrusion 491, which then allows the clip 442 to disengage from the sliding
lock 445. FIG.
12EE shows the sandwiching of the clip 442 and FIG. 12FF illustrates the clip
moving
downward beyond the protrusion 491 where it can be released. FIG. 12GG
illustrates the
44
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
clip 442 being released, so the safety cap 440 can be completely removed. Once
this is done
the system 400 is fixed in a state, such as shown in FIG. 12AA where the
plunger rod 480A
is completely depressed, except this time, the lever 420 cannot be extended.
As a result,
when the delivery needle pierces the delivery septum the force from constant
force spring
410 continues to act on plunger rod 480B, which now drives plunger 474B to act
on the
mixed medicament 482 currently in container 464B to forced out of container
464B through
the fluid communication assembly 450 and out through the delivery needle 492
into a
recipient. The force causing the delivery needle 492 can occur in several
ways, which are
known and previously described including a direct force on the delivery needle
or delivery
needle assembly, a force on the needle shield assembly, which helps drive the
distal end of
the delivery needle through the delivery septum and other methods known. Thus,
the system
is configured to automatically inject the mixed medicament into a recipient
using the energy
provided by the force of the constant force spring, which during the delivery
can no longer
act on the plunger rod 480A, which is now in a locked position.
11911 As a result of the embodiments conveyed above, it should be understood
that some of
the additional advantages of the systems provided herein, allow for a
convenient
reciprocating transfer of medicament components between cartridges or
containers until the
user is ready to deliver those components. The counteracting forces from the
user input in
the latter three embodiments, can also be redirected to become the delivery
force for the
mixed medicament. The mutli-directional valve and vent obstruction components
of the
initial embodiment disclosed in a similar manner help direct energy from the
gas chamber in
a particular to also deliver the mixed medicaments into the user. This ease of
reciprocating
and transferring medicaments and redirecting of energy of the energy sources
provided to
aid in the delivery of the medicament components are some of the improvements
over the
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
WO 2022/251749
PCT/ITS2022/031667
current state of the art and facilitate the mixing of difficult to mix
medicament components
as previously noted.
[192] It should also be understood that the systems can be designed to
explicitly be
delivered from a particular container or designed to be delivered from the
container the
current mixed medicament resides or from both containers simultaneously. It
should also be
noted that the system can include wet and dry, as well as wet and wet
medicament
components.
[193] It should be noted the size of the containers can be the same or they
can vary in size.
For example, a 3mL and 5mL or two 3mL containers could be used. However, this
invention
and these embodiments should not be limited to these particular sizes alone
and these
provided as examples.
[194] While the principles of the invention have been described herein, it is
lobe
understood by those skilled in the art that this description is made only by
way of example
and not as a limitation as to the scope of the invention. Other embodiments
are contemplated
within the scope of the present invention in addition to the exemplary
embodiments shown
and described herein. Modifications and substitutions by one of ordinary skill
in the art are
considered to be within the scope of the present invention.
46
CA 03220558 2023- 11- 27
SUBSTITUTE SHEET (RULE 26)
